Personalized vs Standard Antibiotic Duration for Gram-Negative Blood Infections in Hospitalized Patients with Blood Cancers and Febrile Neutropenia

What this Trial Is About

This clinical trial focuses on hospitalized patients with hematologic malignancies, such as leukemia or lymphoma, who develop febrile neutropenia and Gram-negative bacteraemia. It aims to evaluate whether a personalized duration of antibiotic therapy based on clinical stability is as effective as the standard treatment lasting at least 10 days. The study also investigates how different antibiotic durations impact the recovery and composition of gut microbiota in these high-risk patients. Participants are randomly assigned to one of two groups the personalized duration group, where antibiotics are stopped after the patient maintains clinical stability no fever and stable vital signs for 72 consecutive hours, and the standard of care group, where antibiotics are continued for at least 10 days following usual clinical practice. In addition to treatment, a microbiological sub-study collects blood, feces, and rectal swab samples at specified times to analyze intestinal and blood microbiota and antibiotic resistance genes using advanced sequencing techniques. Throughout the 28-day monitoring period, participants are observed for new fever episodes, infection recurrence, and survival. Those in the sub-study provide biological samples at onset of fever, end of treatment, and day 28. Researchers assess days free from anti-Gram-negative antibiotic therapy, incidence of new fevers, bloodstream infection relapses, and antibiotic-related adverse events. Safety monitoring includes tracking the emergence of multi-drug resistant organisms and Clostridioides difficile infection during and after treatment.

Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients